Kornimate/medical-research-clean huggingface dataset:
"steroids and azathioprine versus steroids alone in igan"

Conditions: IGA Nephropathy

Summary: in a previous trial the investigators found that the effect of steroids in iga nephropathy diminish over time. the difference in renal survival is striking up till the third year, but then remains constant. a six-month course of steroid therapy may be not enough to ensure a stable remission. the investigators hypothesized that a more aggressive treatment may obtain long-term better results. the investigators conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult igan patients.

in 1999, we published a multicenter, randomized, controlled trial, which compared a 6-month steroid course with supportive therapy in 86 patients with igan. after 5 years of follow-up, the risk of a 50% increase in plasma creatinine from baseline was significantly lower in the treated patients; proteinuria also decreased. however, the effect of steroids seemed to diminish over time. the difference in renal survival was particularly striking up till the third year, but then remained constant. we hypothesised that a six-month course of steroid therapy is not enough to ensure a stable remission, and a more aggressive treatment may be required to obtain long-term better results. at this regard, some studies of combined treatment with corticosteroids and azathioprine found that treatment was effective in preserving renal function and in reducing proteinuria. however, these studies did not clarify whether azathioprine added further benefit to steroids in the long term. we conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult igan patients.

Eligibility criteria:
inclusion criteria: * biopsy proven iga nephropathy * creatinine ≤ 2.0 mg/dl for at least three months * proteinuria ≥ 1.0 g/day for at least three months exclusion criteria: * treatment with steroids or cytotoxic drugs during the previous three years * contraindications to steroids or azathioprine * henoch-schöenlein purpura * diabetes mellitus * severe hypertension (diastolic blood pressure \> 120 mmhg) * lupus erythematosus systemicus * malignancies * active peptic-ulcer disease * pregnancy * viral hepatitis or other infections

Keywords: iga nephropathy steroids azathioprine chronic kidney disease progression proteinuria
establishing a data base for aplastic anemia and other marrow failure syndrome

Conditions: Aplastic Anemia and Other Marrow Failure Syndrome

Summary: establishing a data base for aplastic anemia and other marrow failure syndrome

establishing a data base for aplastic anemia and other marrow failure syndrome

Eligibility criteria:
inclusion criteria: * patients with diagnosed aplastic anemia and other marrow failure syndrome database. exclusion criteria: * patients with diagnosis other than aplastic anemia and other marrow failure syndrome database.

Keywords: aplastic anemia marrow failure syndrome
intrathecal dexmedetomidine versus intrathecal morphine inpatients undergoing cardiac valve replacement surgeries

Conditions: Cardiac Valve Disease

Summary: comparison between the effects of intrathecal morphine versus intrathecal dexmedetomidine on analgesia and respiratory function, in open heart surgery.

postoperative pulmonary dysfunction is a well-recognized complication of open-heart surgeries. about 25% of patients who don't present with any severe impaired cardiac function reported to have significant pulmonary dysfunction for at least one week after operation. many mechanisms could be accused of this dysfunction as respiratory mechanics failure by diaphragmatic paresis or paralysis, pain and muscle guarding, lung atelectasis, drains discomfort, etc. although pain is the major concern of patients, but sometimes it may not get the proper attention, pain in open heart surgery origins mainly from the surgical incision which is here a median sternotomy the most commonly used approach and the easiest access to the heart region, however median sternotomy may significantly impedes the pulmonary function by the resultant pain of this procedure and cause morbidity and mortality by itself

Eligibility criteria:
inclusion criteria: - cardiac patient scheduled for elective open heart valve replacement surgery. exclusion criteria: * • patient refusal * coagulation disorders * history of known allergy to the used drugs. * combined procedures (e.gif combined with coronary artery bypass or aortic root surgeries). * if thoracotomy or min-sternotomy is planned for the surgery. * re-do and emergency surgeries. * history of chronic chest diseases (copd or ipf). * history of thoracotomy, pneumothorax, pneumomediastinum, phrenic nerve injury (as evident by the presence of paralysis of the ipsilateral hemidiaphragm when examined preoperatively). * neuromuscular diseases. * brain injuries.
a walking intervention through text messaging

Conditions: Physical Activity; Behavior; Overweight; Motor Activity

Summary: the purpose of this study is to develop and evaluate adaptive goal setting and feedback interventions (adaptive interventions) to promote physical activity behaviors and compare it to static physical activity interventions (static interventions) using two levels of goal setting (adaptive goals vs. static goals) and two levels of reinforcement procedures (praise/rewards and no praise/rewards) in a 2 x 2 factorial randomized controlled trial. all four groups will receive the intervention via a semi-automated text message system developed by the investigators study team. the primary aim of this study will be to: 1. evaluate whether the adaptive interventions result in greater change in physical activity (pedometer-measured steps/day) compared to the static intervention groups. hypotheses: participants in the adaptive interventions will increase their steps/day more than participants in the static intervention groups. the adaptive goals and reinforcement group will outperform the other 3 groups. the secondary aims of this study will be to: 2. evaluate the effectiveness of the adaptive and static goal interventions in improving anthropometric, cardiovascular fitness, and cardiometabolic risk factors. hypotheses: participants in the adaptive interventions will show greater improvements in fitness, lean and fat body mass, and serum biomarkers than participants in the static intervention groups. the adaptive goals and reinforcement group will outperform the other 3 groups. 3. to assess participants' satisfaction with the overall program.


Eligibility criteria:
inclusion criteria: * women and men of all races/ethnicities living in maricopa county, arizona. exclusion criteria: * be between 18 and 60 years old * currently not exceeding physical activity recommendations determined by the international physical activity questionnaire (ipaq short form). * not have a medical condition based on the physical activity readiness questionnaire for everyone (par-q+) that requires supervised physical activity * not taking medication(s) that would prohibit a moderate intensity physical activity program * have a body mass index between 25 and 55 kg/m2 * not be currently pregnant or planning to become pregnant in the next 4 months * not be planning to leave maricopa county for 10 days or more in the next 4 months * not planning to move from maricopa county in the next 4 months * not currently in another physical activity, diet, or weight loss program (e.g. weight watchers) * have access to microsoft windows (xp, vista, 7, 8) or mac (10.5+) operating systems on computer with a usb port on a daily basis * have daily access to email and the internet * have a mobile phone with text messaging capabilities and be willing to send and receive up to 3-5 text messages per day.
health related qol, depression and lifestyle changes in insulin resistant adolescents

Conditions: Insulin Resistance; Depression

Summary: the purpose of this study is to assess adolescents with insulin resistance syndrome for quality of life and altered health related issues.

matched historical control study designed to examine outcomes on insulin resistant adolescents who were treated in the insulin resistance syndrome clinic at children's mercy hospital in the past year. new patients will be screened at baseline, 4 and 12 months to evaluate if there is improvement in the bmi z-score, hga1c, lipid profile or waist circumference when depression and/or altered health related quality of life are identified and treated in this population.

Eligibility criteria:
inclusion criteria: * patients 11-17 years of age who are seen in the insulin resistance clinic for the first time * historical control: patients 11-19 years of age seen in the insulin resistance clinic during the prior four months exclusion criteria: * co-morbid syndrome (downs, turner's, prader willi etc) * diagnosis of type 2 diabetes * taking metformin before the initial visit * taking medication for or diagnosis of a psychiatric condition prior to initial visit * developmentally delayed

Keywords: health-related quality of life
a 24-week treatment study to compare standard of care versus the emdpi ds in participants 13 years or older with asthma

Conditions: Asthma

Summary: the primary objective of this study is to demonstrate the effectiveness of the digital system (ds) in improving asthma control compared to the standard of care (soc) group. the secondary objective is to describe the asthma management actions by investigational center health care providers (ihcps) for all participants in both groups, to evaluate short-acting beta2 agonist (saba) usage and the number of saba-free days in the ds group, to evaluate adherence patterns to maintenance treatment (fs emdpi) in the ds group, to assess behavioral correlates of responsiveness to digital health technology among participants for all participants in both groups, to evaluate work productivity and activity impairment in asthma participants in both groups, to assess the usability and acceptability of the ds by participants in the ds group and the investigational center personnel, and to evaluate the safety of fs emdpi and albuterol emdpi.

study duration will be approximately 27 weeks including a one-week screening period, 24 week treatment period, and a 2 week follow-up period.

Eligibility criteria:
inclusion criteria: * the participant has a documented diagnosis of asthma established at the investigational center at the time of informed consent or the investigator confirms a diagnosis of asthma. * the participant is currently on treatment with a moderate- to high-dose inhaled corticosteroid (ics) with long-acting beta agonist (laba). * the participant has an asthma control test score of less than 19 at the screening or baseline visit. * the participant is willing to discontinue all other maintenance ics with laba medications and rescue medications and replace them with the study-provided fluticasone propionate/salmeterol (fs) multidose dry powder inhaler with integrated electronic module (emdpi) and albuterol emdpi, respectively, for the duration of the trial, if randomized to the digital system group. all other asthma maintenance medications, except for ics with laba, may be continued. * additional criteria apply, please contact the investigator for more information. exclusion criteria: * the participant is currently being treated prior to enrollment with a digital inhaler system, including the digihaler system or an external "bolt on" digital system designed to monitor inhaler usage, such as the propeller health or adherium systems. * the participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma, which in the view of the investigator would preclude participation. * the participant was hospitalized for severe asthma in the last 30 days. * the participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study. * additional criteria apply, please contact the investigator for more information.
medam (menopur retrospective data program)

Conditions: Infertility, Female

Summary: french, non-interventional, retrospective, multicentric analysis of patients who have undergone a controlled ovarian stimulation (cos) for in-vitro fertilization (ivf)/ intracytoplasmic sperm injection (icsi). the main objective is to determine the cumulative live birth rate with highly purified menotropin (hp-hmg) which is defined as the occurrence of live birth per started cos, further to transfer of fresh and frozen embryos generated from the same cos.


Eligibility criteria:
inclusion criteria: - patient undergoing a cos with hp-hmg for ivf/icsi cycle from a french data registry between 2009 to 2016 exclusion criteria: * ovulation inductions * intra-uterine inseminations * fertility preservations * oocyte donations

Keywords: menotropin hp-hmg
community awareness, resources and education (care ii) project: project 1

Conditions: Cervical Cancer

Summary: the study hypothesis is that the increased incidence of cervical cancer observed in appalachian women over their non-appalachian counterparts is due in part to inherited and somatic alterations of key components of the transforming growth factor β (tgfβ) signaling pathway.

this project is a case control study that is designed to determine prevalence of inherited polymorphic and somatically acquired variants of key tgf-ß pathway components in a large cohort of appalachian invasive cervical cancer (icc) patients compared to healthy appalachian women. it will be determined whether these genetic alterations contribute individually or in combination with other known environmental (human papillomavirus, epstein-barr virus), behavioral (smoking), and social (stress, social networks) risk factors, to the increased susceptibility of appalachian women to icc development. women will be recruited from several clinics and physician practices in west virginia, charleston and appalachia ohio and kentucky. participants will be women residing in these area who are 18 years and older, not pregnant, speak english, not cognitively impaired and able to provide informed consent. there will be three distinct types of women recruited into the study; 1. arm 1 - previously treated for invasive cervical cancer; 2. arm 2 - newly diagnosed with invasive cervical cancer; and 3. healthy controls - without a diagnosis of cervical cancer.

Eligibility criteria:
inclusion criteria: * 18 years and older * patients previously or newly diagnosed with invasive cervical cancer * healthy women without a diagnosis of any type of cancer * english speaking * able to provide informed consent, biological and questionnaire data. exclusion criteria: * pregnant women

Keywords: appalachia
wellness program for elementary school personnel

Conditions: Obesity; Cardiovascular Diseases

Summary: the goal of the project is to develop, implement, and evaluate, through a randomized controlled trial at a worksite, an intervention to promote increased physical activity behavior and healthier eating behavior to reduce overweight and obesity among elementary school personnel.

background: the dramatic increase in the prevalence of overweight and obesity among adults in the united states during the past two decades is related to increased cardiovascular disease, hypertension, dyslipidemia, diabetes, and other chronic diseases. with 63.9% of working-age adults employed, worksites are targets for prevention and intervention programs to control overweight and obesity. worksite interventions have the potential to reach a large number of individuals in a common and shared environment. design narrative: this is a group-randomized trial involving 20 elementary schools in jefferson parish public schools. schools will be the unit of randomization; 10 schools will be randomly allocated to implement the intervention, and 10 schools will serve as controls. the primary aim of the program is to reduce mean body weight. secondary aims relate to changes at both the individual level and the environmental level. the intervention will address the two major determinants of overweight and obesity: physical activity and diet. a school wellness committee at each site will be instrumental in identifying and implementing components of the intervention.

Eligibility criteria:
inclusion criteria: * healthy adults with no contraindications to participating in an intervention to improve eating and exercise behaviors * healthy adults with no contraindications to participating in any of the measurement procedures exclusion criteria: * inability to participate in routine physical activity
a single dose safety, tolerability, pharmacokinetic and food effect study of kvd900 (sebetralstat) in healthy volunteers

Conditions: Hereditary Angioedema

Summary: a safety, tolerability, pharmacokinetic and food effect study of kvd900 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male subjects between 18 and 55 years of age. * healthy subjects as determined by past medical history and as judged by the chief investigator or designee. * male subject willing to use a highly effective method of contraception. * subject with a body mass index (bmi) of 18-32 kg/m2. * subject with no clinically significant history of previous allergy or sensitivity to kvd900 or any of the excipients contained within the investigational medicinal product (imp). * subject with no clinically significant abnormal serum biochemistry, haematology, clotting profiles, and urine examination values within 28 days before the first dose of imp. * subject with a negative urinary drugs of abuse screen, determined within 28 days before the first dose of imp * subject with negative human immunodeficiency virus (hiv) and hepatitis b surface antigen (hep b) and hepatitis c virus antibody (hep c) results. * subject with no clinically significant abnormalities in 12-lead electrocardiogram * subjects must not donate sperm from first dose until at least 3 months after last dose of imp. * subjects without any special food restrictions that would hinder ability to consume the high fat breakfast provided during study part c; such as lactose intolerance , vegan, low-fat, low sodium, etc. * subjects with no known allergy or sensitivity to lactose and/or any additional excipients contained in imp. * subject must be available to complete the study (including all follow up visits). * subject must satisfy the chief investigator or designee about their fitness to participate in the study. * subject must provide written informed consent to participate in the study. exclusion criteria: * a clinically significant history of gastrointestinal disorder likely to influence imp absorption. * use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements . * evidence of renal, hepatic, central nervous system, respiratory, cardiovascular (no history of syncope or vasovagal events), or metabolic dysfunction. * subjects with a history of clotting abnormalities. * a clinically significant history of drug or alcohol abuse in the last 5 years. * users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to dosing with the study medication or users of cigarette replacements. * inability to communicate well with investigators. * participation in a new chemical entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the first dose of imp. * donation of 450 ml or more blood within the 3 months before the first dose of imp.

Keywords: sebetralstat
safety study of lenalidomide with and without dexamethasone in japanese subjects with previously treated multiple myeloma

Conditions: Multiple Myeloma

Summary: cc-5013-mm-017 is a phase i, multicenter study to determine the maximum tolerated dose (mtd), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in japanese subjects with previously treated mm. the study will consist of two cohorts: 1) monotherapy "maximum tolerated dose (mtd) determination" cohort; and 2) "combination treatment" cohort.


Eligibility criteria:
inclusion criteria: * subjects with previously treated multiple myeloma * measurable levels of m-protein in serum \>= 0.5 g/dl \[5g/l\]) or urine (\>= 0.2 g excreted in a 24-hour collection sample) * ecog performance status of 0 - 2 * willing to follow pregnancy precautions exclusion criteria: * patients with acute an myocardial infarction (mi) within the past 6 months, or patients with a history of deep vein thrombosis (dvt) or pulmonary embolism (pe) within the past 3 years * patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases * patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma * patients with posterior subcapsular cataracts * patients with mental illness * patients with past histories or complications which make the investigator or other staff member deem them inappropriate for this study * pregnant or lactating females * grade 2 or worse neuropathy * any of the following laboratory abnormalities: absolute neutrophil count (anc) \ 2.5 mg/dl serum sgot/ast or sgpt/alt \> 3.0 x upper limit of normal (uln) * prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for \>= 3 years. - patients who received radiation therapy within 14 days of the start of study drug * patients with scars from a recent viscus operation * patients with history of a desquamating (blistering) rash while taking thalidomide * patients with prior use of lenalidomide * patients with known hiv positivity. * patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or other experimental agents (agents that are not commercially available) intended for the treatment of mm within 28 days of the start of lenalidomide therapy. * patients with known history of hypersensitivity to dexamethasone.
a comparison of midazolam and zolpidem as oral premedication in children

Conditions: Parental/Caregiver Anxiety; Child's Anxiety

Summary: the purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. subjects will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to surgery. no placebo will be administered in this study. subjects will be male and female children between 2 and 9 years of age. in total, subject participation will last approximately the duration of their preoperative, perioperative, and immediate postoperative period. a member of the research team will recruit subjects preoperatively in the operating room holding area prior to surgery. consent will take place at the time of recruitment in the preoperative holding area following a detailed explanation of the study and medications involved in the study. participants will be of asa (american society of anesthesiologists) class i-ii, undergoing surgical procedures of at least 2 hours duration, and expected to remain inpatient for at least 23 hours postoperatively.


Eligibility criteria:
inclusion criteria: * pediatric patients ages 2-9 years * asa class i-ii * inpatient surgeries of at least 2 hours duration * requiring postoperative admission of at least 23 hours exclusion criteria: exclusion criteria: * contraindication to preoperative sedation, known allergy or sensitivity to the study medications, * those who lack legal representative consent * patients with weights lying below the 5th percentile or above the 95th percentile according to the current published cdc growth chart will also be excluded regardless of existing specific contraindication.

Keywords: pre-medication pre-operative anxiety